Sr. Pharmacovigilance Specialist

Par Health; Hazelwood (MO); Sur place; USD 80 000 - 100 000; Plein temps

Résumé du poste

A healthcare organization in Hazelwood is looking for a Senior Pharmacovigilance Specialist to manage adverse event reports and ensure compliance with global regulations. The ideal candidate will have at least 5 years of clinical experience and thorough knowledge of safety reporting. This role necessitates strong communication skills and experience with adverse events management. The position involves independent work within a collaborative team environment and offers opportunities for professional development through occasional travel.

Qualifications

• Minimum of 5 years clinical experience in a relevant environment.
• Minimum of 3 years experience with post-marketing adverse events.
• Thorough knowledge of US and ICH safety reporting regulations.

Responsabilités

• Collect and document adverse event reports.
• Process and report serious adverse events.
• Review reports for quality and ensure regulatory compliance.

Connaissances

Knowledge of clinical areas

Reviewing and summarizing medical records

Excellent verbal and written communication

Computer applications (Word, Excel, PowerPoint)

Reporting and management of adverse event reports

Writing safety summaries

Formation

Bachelor’s degree with healthcare certification

Description du poste

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

The primary responsibility of the Senior (Sr.) Pharmacovigilance (PV) Specialist is to collect, accurately document, assess, code and process adverse event reports related to the marketed products monitored by the Par Health PV within the time frames established by Par Health PV and in compliance with global regulatory requirements as well as Safety Data Exchange Agreements. The Sr. PV Specialist will serve as a primary contact point and recipient for adverse events, manage processing and reporting of serious adverse events received during Company‑sponsored clinical trials, and oversee PV Vendor/contracted research organization (CRO) handling pharmacovigilance activities on behalf of Par Health. The Sr. PV Specialist is also responsible for handling related safety inquiries for internal and external customers and will be involved in analyses of safety data, establishing relationships globally to ensure compliance, and cross‑training to handle other functions as necessary.

Job Description

ESSENTIAL FUNCTIONS: The Sr PV Specialist will either perform the essential functions or will be involved in the oversight of the functions if handled by a PV vendor/contract research organization. Responsibilities include collecting and documenting adverse event reports, triaging incoming information for completeness and seriousness, processing events in the Par Health Safety System, reviewing reports for quality, preparing and submitting expedited reports to regulatory authorities, prioritizing PV functions, reviewing medical literature search results, performing queries, ensuring compliance with Safety Data Exchange Agreements, executing searches, integrating new products into the PV system, providing support during audits, compiling data for Aggregate Safety Reports, distributing PV data, elevating potential safety signals, initiating investigations, ensuring proper event handling, staying current with regulations, and communicating with multiple departments.

Department Specific/Non‑essential Functions Other duties as assigned with or without accommodation. Maintain or hold an active professional licensure in accordance with State and Federal Laws.

Education

MINIMUM REQUIREMENTS: Minimum of a Bachelor’s degree with a healthcare certification required (i.e., RN, RPh, PharmD, Physician’s Assistant, Nurse Practitioner, Respiratory Therapist, Veterinarian, etc.).

Experience

A minimum of 5 years clinical/practical experience in a relevant clinical environment, a minimum of 3 years experience with reporting post‑marketing adverse events in the pharmaceutical industry (including experience with a PV database), and thorough knowledge of US and ICH safety reporting regulations and guidelines.

Skills/Qualifications

• Knowledge of the clinical areas for Par Health marketed products and knowledge in the review and analysis of the medical literature.
• Demonstrable skills in reviewing and summarizing medical records.
• Excellent verbal and written communication skills, including excellent telephone etiquette, and comfort handling discussions with patients and healthcare providers on health and medical topics.
• Strong experience in computer applications such as Microsoft Word, Excel, and PowerPoint, and willingness to expand competencies.
• Extensive experience in the reporting and management of adverse event reports.
• Experience in writing safety summaries.

Skills/Competencies

Committed, self‑motivated team player. Exceptional problem‑solving skills. Ability to meet the demands of a dynamic organization. Ability to operate independently by planning, scheduling and arranging activities to accomplish objectives. Ability to meet internal and external deadlines. Outstanding organizational abilities.

Organizational Relationships/Scope

The Sr. PV Specialist reports directly to the Senior Manager, Pharmacovigilance, operates independently under limited supervision, and participates in determining work objectives. The Sr. PV Specialist works closely with members of Global PV, Regulatory Affairs, Clinical Operations, Medical Information, Product Monitoring and Legal.

Working Conditions

Normal office environment. Occasional travel required for professional training seminars, workshops, conferences and off‑site business meetings.

Disclaimer

The above statements describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

EEO Statement

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state, or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.